From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD.
FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years The US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically.
Annex I to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0 and Annex II to the HMA eSubmission Roadmap on the implementation of mandatory eCTD format for regulatory submissions were adopted by the eSubmission Change Management Board (CMB) on 17th December 2014, and are now available here.
An electronic repository for periodic safety update reports (PSURs) and their assessment reports was launched by the European Medicines Agency (EMA). The central platform was created in accordance with the pharmacovigilance legislation of the European Union (EU) and will contain all information related to PSURs in the EU. It will facilitate the assessment of PSURs […]
Two Final Guidance for Electronic Submissions published by US FDA in December 2014 Providing Submissions in Electronic Format — Standardized Study Data https://lnkd.in/eUhwjj5
Romania will join the Common Repository to receive Centralised Procedure submissions from 1st January 2015. The majority of the NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository […]
Following is the list of recent EMA”s updates with links to updated documents/guidelines:
US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically.
The specification for the Australian electronic Common Technical Document (eCTD) format submissions.
From 1 July 2015, new market authorisation applications for decentralised procedures must be submitted in electronic common technical document (eCTD) format.